This invention pertains to a novel therapeutic composition comprising hydrocodone. The invention concerns also a novel dosage form comprising hydrocodone. Additionally, the invention relates to a novel method of administering a dose of hydrocodone from a therapeutic composition, and to a novel method of administering a dose of hydrocodone from a dosage form that in both administrations are for producing antitussive and analgesic therapy.
Hydrocodone is chemically 4, 5-epoxy-3-methoxy-17-methyl-morphinan-6-one. The synthesis of hydrocodone and its pharmaceutically acceptable acid addition salts are described in U.S. Pat. No. 2,715,629 issued to Pfister et al, and in the Merck Index, 11th Edition, page 757, entry 4708 (1989). Hydrocodone is a narcotic antitussive and analgesic. The mechanism of physiological and pharmacological actions of hydrocodone is believed that it acts directly by depressing the cough centers for its antitussive therapy. At antitussive doses, hydrocodone exerts also analgesic effects. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-dimethylation and 6-keto reduction to the corresponding 6-xcex2-hydroxy metabolites.
The prior art administers hydrocodone in conventional tablet and syrup forms, which forms dose-dump hydrocodone thereby providing a concentration of hydrocodone followed by an absence of hydrocodone. This pharmaceodynamic variability with its fluctuation in hydrocodone availability to hydrocodone receptor sites produces uncertainty as it is unknown if a dose of hydrocodone is present for needed therapy. The prior art is deficient in providing controlled hydrocodone therapy to a patient seeking such therapy. The pharmacological properties of hydrocodone are known in The Pharmacological Basis of Therapy, by Gilman and Rall, 8th Edition, pg. 497, (1990); and in Pharmaceutical Sciences, Remington, 17th Ed., pg. 1104, (1985).
In view of the foregoing presentation, it is immediately apparent that a present and critical need exists for an improvement in the delivery of hydrocodone for its therapeutic antitussive and analgesic effects. The need exists for providing a novel therapeutic composition comprising hydrocodone, the need exists for providing a novel dosage form comprising hydrocodone, and the need exists for providing a novel method for administering hydrocodone to a patient in need of hydrocodone therapy. It is, therefore, an object of this invention to provide a therapeutic composition comprising hydrocodone with means for enhancing the administration of hydrocodone over time. It is also an object of the invention to provide a dosage form with means for controlling the delivery of hydrocodone that overcomes fluctuation in hydrocodone therapy. It is an additional object of the invention to provide a method for administering hydrocodone for better hydrocodone therapy.
The drug hydrocodone, as embraced by this invention, comprises a member selected from the group consisting of hydrocodone and its pharmaceutically acceptable salts. Representative of hydrocodone pharmaceutically acceptable salts comprises a member selected from the group consisting of hydrocodone bitartrate, hydrocodone bitartrate hydrate, hydrocodone hydrochloride, hydrocodone p-toluenesulfonate, hydrocodone phosphate, hydrocodone thiosemicarbazone, hydrocodone sulfate, hydrocodone trifluoroacetate, hydrocodone, hydrocodone bitartrate, dihydrocodeinone bitartrate, hydrocodone bitartrate hemipentahydrate, pentafluoropropionate, hydrocodone p-nitrophenylhydrazone, hydrocodone o-methyloxime, hydrocodone semicarbazone, hydrocodone hydrobromide, hydrocodone mucate, hydrocodone oleate, hydrocodone phosphate dibasic, hydrocodone phosphate monobasic, hydrocodone inorganic salt, hydrocodone organic salt, hydrocodone acetate trihydrate, hydrocodone bis(heptafuorobutyrate), hydrocodone bis(methylcarbamate), hydrocodone bis(pentaflu oropropionate), hydrocodone bis(pyridine carboxylate), hydrocodone bis(trifluoroacetate), hydrocodone chlorhydrate, and hydrocodone sulfate pentahydrate.